Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis
NCT ID: NCT00811395
Last Updated: 2012-12-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
182 participants
INTERVENTIONAL
2007-10-31
2010-04-30
Brief Summary
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Secondary objectives were to evaluate the long-term effect on relapse rate, disability progression and Magnetic Resonance Imaging \[MRI\] parameters.
This study is the extension study of the PDY6045 (NCT00489489) and PDY6046 (NCT00475865) studies. Participants who successfully completed the initial study were offered to continue their treatment (same compound, same dose) for 24 additional weeks.
Detailed Description
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* 24-week double-blind treatment period,
* 16-week post-treatment elimination follow-up period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo + IFN-β
Placebo (for teriflunomide) once daily concomitantly with interferon-β \[IFN-β\] for 24 additional weeks
Placebo (for teriflunomide)
Film-coated tablet
Oral administration
Interferon-β [IFN-β]
Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection
Teriflunomide 7 mg + IFN-β
Teriflunomide 7 mg once daily concomitantly with interferon-β \[IFN-β\] for 24 additional weeks
Teriflunomide
Film-coated tablet
Oral administration
Interferon-β [IFN-β]
Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection
Teriflunomide 14 mg + IFN-β
Teriflunomide 14 mg once daily concomitantly with interferon-β \[IFN-β\] for 24 additional weeks
Teriflunomide
Film-coated tablet
Oral administration
Interferon-β [IFN-β]
Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection
Placebo + GA
Placebo (for teriflunomide) once daily concomitantly with glatiramer acetate \[GA\] for 24 additional weeks
Placebo (for teriflunomide)
Film-coated tablet
Oral administration
Glatiramer Acetate [GA]
Solution in prefilled syringe for subcutaneous injection
Teriflunomide 7 mg + GA
Teriflunomide 7 mg once daily concomitantly with glatiramer acetate \[GA\] for 24 additional weeks
Teriflunomide
Film-coated tablet
Oral administration
Glatiramer Acetate [GA]
Solution in prefilled syringe for subcutaneous injection
Teriflunomide 14 mg + GA
Teriflunomide 14 mg once daily concomitantly with glatiramer acetate \[GA\] for 24 additional weeks
Teriflunomide
Film-coated tablet
Oral administration
Glatiramer Acetate [GA]
Solution in prefilled syringe for subcutaneous injection
Interventions
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Teriflunomide
Film-coated tablet
Oral administration
Placebo (for teriflunomide)
Film-coated tablet
Oral administration
Interferon-β [IFN-β]
Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection
Glatiramer Acetate [GA]
Solution in prefilled syringe for subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* completed the week 24 visit of either study PDY6045 or PDY6046,
* was still meeting eligibility criteria for receiving treatment,
* had agreed to continue stable dose of Interferon-β \[IFN-β\] or Glatiramer Acetate \[GA\] and consented to continue on treatment.
Exclusion Criteria
The above information is not intended to contain all considerations relevant to patient's potential participation in a clinical trial.
18 Years
55 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Vienna, , Austria
Sanofi-Aventis Administrative Office
Laval, , Canada
Sanofi-Aventis Administrative Office
Berlin, , Germany
Sanofi-Aventis Administrative Office
Milan, , Italy
Sanofi-Aventis Administrative Office
Barcelona, , Spain
Sanofi-Aventis Administrative Office
Guildford, , United Kingdom
Countries
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References
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Freedman MS, Wolinsky JS, Wamil B, Confavreux C, Comi G, Kappos L, Olsson TP, Miller A, Benzerdjeb H, Li H, Simonson C, O'Connor PW; Teriflunomide Multiple Sclerosis Trial Group and the MRI Analysis Center. Teriflunomide added to interferon-beta in relapsing multiple sclerosis: a randomized phase II trial. Neurology. 2012 Jun 5;78(23):1877-85. doi: 10.1212/WNL.0b013e318258f7d4. Epub 2012 May 23.
Freedman MS, Wolinsky JS, Truffinet P, Comi G, Kappos L, Miller AE, Olsson TP, Benamor M, Chambers S, O'Connor PW. A randomized trial of teriflunomide added to glatiramer acetate in relapsing multiple sclerosis. Mult Scler J Exp Transl Clin. 2015 Dec 7;1:2055217315618687. doi: 10.1177/2055217315618687. eCollection 2015 Jan-Dec.
Other Identifiers
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HMR1726D/2005
Identifier Type: OTHER
Identifier Source: secondary_id
2007-003997-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LTS6047
Identifier Type: -
Identifier Source: org_study_id